New & Noteworthy

January 2026

Biosimilars

Fresenius Kabi USA

Fresenius Kabi has received US FDA approval to make its biosimilars Conexxence and Bomyntra interchangeable with Prolia and Xgeva. Conexxence (denosumab-bnht) is approved for use in adult patient populations at high risk for fractures, including individuals with osteoporosis, those undergoing certain cancer treatments that affect bone density, and patients receiving long-term glucocorticoid therapy. In the US, it carries a boxed warning and includes a Risk Evaluation and Mitigation Strategy (REMS) program. Bomyntra (denosumab-bnht) is approved for the prevention of skeletal-related events in patients with multiple myeloma and in patients with bone metastases from solid tumors, and is also indicated for the treatment of hypercalcemia of malignancy that is refractory to bisphosphonate therapy.

Request More Information

Current Issue